Process Development Scientist

Requirements

• Must meet one of the following education and experience requirements: Doctorate (Ph.D.) in a scientific discipline; or Master's degree in a scientific discipline with 2+ years of relevant scientific experience; or Bachelor's degree in a scientific discipline with 4+ years of relevant scientific experience.
• Experience in a commercial bio pharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• Understanding of protein science, formulation processes, and aseptic filling operations
• Experience with process monitoring, data analysis, trending, and statistical software (e.g., JMP)
• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
• Experience providing direct manufacturing floor support in a fast-paced, GMP-regulated production environment.
• Strong technical writing skills with experience preparing documentation for regulatory inspections and audits.
• Excellent communication, presentation, problem-solving, and project management skills.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Bilingual proficiency in English and Spanish (written and verbal).
• Work schedule: 8:00 am to 5:00 pm (admin shift). However, staff will support a 24/7 formulation and filling operations, and irregular shifts, including extended hours (12 hrs), nights, weekends, or holidays may be required based on business needs.